RecruitingNot ApplicableNCT04796792

Ultrasound to Facilitate Stone Passage

Ultrasound Technology to Fragment and Reposition Urinary Stones


Sponsor

University of Washington

Enrollment

140 participants

Start Date

Apr 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, open-label, multi-center study to test the clinical feasibility of facilitating stone passage by the combination of breaking and repositioning stones with ultrasound, without the need for anesthesia.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether focused ultrasound can help push kidney stones through the urinary tract so they pass naturally — without surgery or shockwave lithotripsy. Small kidney stones (2–7 mm) often pass on their own, but they can take weeks and cause significant pain. Researchers are using a specially designed ultrasound device to apply gentle, targeted pulses to the stone, aiming to nudge it along the ureter toward the bladder. The study is for adults who have a confirmed kidney stone and are being managed non-surgically. Some participants also have spinal cord injuries (Phase 2b). The ultrasound procedure is performed in a clinic, and participants are followed to see whether the stone passes faster and with fewer complications compared to standard watchful waiting. You may be eligible if... - You are 18 years or older - You have at least one kidney stone between 2 mm and 7 mm in size confirmed by imaging - You are able to follow up as required - You can read and understand English You may NOT be eligible if... - You are pregnant or trying to become pregnant - You have a solitary kidney - You have an uncorrected bleeding disorder or are on anticoagulants you cannot pause - You have an uncorrected urinary tract obstruction or active infection - You have a calcified abdominal or renal artery aneurysm on the same side as the stone - You have previously had two procedures for the same stone Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBurst Wave Lithotripsy (BWL) and Ultrasonic Propulsion (UP)

Novel ultrasound technologies to facilitate passage of stones.This includes Burst Wave Lithotripsy (BWL), a technology to noninvasively fragment urinary calculi within the kidney and ureter, and ultrasonic propulsion, a technology to non-invasively reposition stones within the kidney and ureter. BWL uses short multi-cycle bursts of low amplitude ultrasound to induce stone fracture. This is in contrast to traditional extracorporeal shock wave lithotripsy (SWL), which employs a brief single compression/tensile cycle of high amplitude (shock) waves to achieve stone fracture. Ultrasonic propulsion uses long multi-cycle bursts of low amplitude ultrasound to move stones within the collecting system.


Locations(3)

Indiana University Health - North Hospital

Carmel, Indiana, United States

VA Puget Sound Health Care System

Seattle, Washington, United States

University of Washington

Seattle, Washington, United States

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NCT04796792


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